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Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines

A Phase I Single Site Open Label Clinical Trial for the Development of a Human BCG Challenge Model to Assess TB Drugs and Vaccines.

NCT05592223•Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of the study is to develop a BCG challenge model for use in short term Phase I human trials capable of assessing the ability of TB drugs and/or vaccine-induced immune responses to impact in vivo mycobacterial replication as a method of assessing antimycobacterial agents and/or protective immunity elicited by vaccines or host-directed therapy. The trial will illuminate the nature of local and systemic immune responses to BCG and treatment response, as well as demonstrate our local capacity for newer, more innovative study designs.

Detailed Description

This is phase 1, open-label, randomized clinical protocol to develop a human challenge model using the licensed and available BCG VACCINE USP (TICE® strain) with and without INH or Rifampin (RIF). Part 1 will involve 10 participants who will be screened and consented, given an intradermal injection of BCG; five of these participants will receive oral INH for 3 days. Part 2 will involve 10 participants who will be screened and consented, given an intradermal injection of BCG; five of these participants will receive oral RIF for 7 days. All participants will undergo physical exams, clinical evaluations, blood draws, urine collections, skin biopsies, and pregnancy tests. This study will measure the rate of replication by utilizing qPCR and in vitro culture, systemic innate and adaptive immune responses, including humoral and cellular assay analyses and the evaluation and PPD/IGRA status.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Provide written informed consent prior to initiation of any study procedures,
•Are males or non-pregnant females between the ages of 18 and 45 years, inclusive,
•Women of childbearing potential in sexual relationships with men must use an acceptable method of preventing conception from 30 days prior to 3 months after Tice® BCG administration. Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy or successful device placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \< 1 year of the last menses if menopausal). Includes but is not limited to, sexual abstinence, monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject receiving Tice® BCG, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing ®, and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill").
•For women of childbearing potential, negative serum pregnancy test at screening and negative urine pregnancy test within 24 hours prior to enrollment and Tice® BCG administration,
•Are in good health, as judged by the investigator and determined by vital signs (oral temperature, pulse, and blood pressure), medical history and physical examination,
•Have a negative HIV-1 ELISA test,
•Have negative serology tests for hepatitis B surface antigen and hepatitis C virus antibody,
•Have a negative QuantiFERON-TB Gold test,
•Negative is defined as Nil response \< 0.8 IU/ml and TB Antigen response minus Nil response \<0.35 IU/mL or TB Antigen response minus Nil response \> 0.35 IU/mL and \< 25% of Nil response and Mitogen response minus Nil response \> 0.5 IU/ml,
•Have a urine dipstick for protein less than 1,
+2 more criteria

Exclusion Criteria

•Have a history of suspected, confirmed, treated or have other evidence of active tuberculosis,
•Symptoms may include recurrent fever, fatigue, night sweats, weight loss, oral ulcers, diarrhea, nausea, vomiting, or bleeding,
•Have any systemic symptoms\* within 72 hours before Tice® BCG administration or signs of lymphadenopathy, hepatosplenomegaly, or pulmonary disease by physical examination on day of Tice® BCG administration. Includes fever, chills, malaise, fatigue, headache, night sweats, weight loss, nausea, vomiting, bleeding, diarrhea, abdominal pain, rhinorrhea, cough, wheezing, or shortness of breath.
•Have history of any significant acute or chronic medical conditions\* or need for chronic medications that, in the opinion of the investigator, will interfere with immunity or affect safety. Includes, but is not limited to, disorders of the liver, kidney, lung, heart, or nervous system, or other metabolic or autoimmune/inflammatory conditions. Have any history of excessive scarring or keloid formation.
•Have household contact or occupation involving significant contact with someone who is immunocompromised. Includes persons with HIV, AIDs, or active cancer; infants (children \< 1 year); pregnant women; or persons who are immunosuppressed for approximately 6 weeks (during the time of active ID lesion drainage).
•Have a history of epilepsy (does not include febrile seizures as a child),
•Have a pacemaker, prosthetic valve, or implantable cardiac devices,
•Have a history of bleeding disorder,
•Have a known allergy to any Tice® BCG components (glycerin, asparagine, citric acid, potassium phosphate, magnesium sulfate, iron ammonium citrate, and lactose),
•Received blood products or immunoglobulin within 6 months prior to Tice® BCG administration,
+29 more criteria

Locations (1)

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Key Dates

Start Date

December 6, 2022

Primary Completion Date

August 23, 2023

Completion Date

December 1, 2023

Last Updated

December 16, 2025

Enrollment

ACTUAL participants

Conditions

Tuberculosis

Interventions

BCG Vaccine USP

DRUG

Isoniazid

DRUG

Rifampin

DRUG

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RECRUITINGPHASE2

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RECRUITINGNA

Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines

Inclusion Criteria

Exclusion Criteria

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

Evaluating the Safety and Immunogenicity of MTBVAC

Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)

Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents With Pulmonary MDR-TB

A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.

Rapid Research in Diagnostics Development for TB Network